Briefing Paper

Factsheet

BARCELONA, ASUNCIÓN, LA PAZ, RIO DE JANEIRO/OCTOBER 5, 2011 -- Thousands of people with Chagas disease will go untreated in coming months due to a shortage of benznidazole, the first-line drug used in most countries where Chagas is endemic. The shortage comes at a time when a number of countries are actively seeking to treat people living with a disease that was neglected for too long. The international medical humanitarian organization Doctors Without Borders/Médecins sans Frontières (MSF) is urging the Brazilian Ministry of Health, which is responsible for the world’s only laboratory that manufactures benznidazole, to respect its commitment to Chagas patients and to take immediate measures to make the drug available.

Chagas treatment depends entirely on a single pharmaceutical company to produce benznidazole tablets, the Brazilian State laboratory LAFEPE (Laboratorio Farmaceutico do Estado de Pernambuco). Production of the drug’s active pharmaceutical ingredient (API) used by LAFEPE was recently transferred to a sole private company, Nortec Química. There is not enough API at present to produce the tablets needed, and Nortec has yet to validate production. In addition, LAFEPE has breached its promise to publish and fulfil a manufacturing schedule that would ensure availability of the drug.

“This situation is unacceptable,” said Dr. Henry Rodríguez, MSF head of mission in Bolivia and Paraguay. “In Boquerón, an area with one of the highest rates of Chagas in Paraguay, we are forced to stop diagnosing patients because we simply don’t have the drugs to treat them. For decades Chagas was a completely neglected disease and just when diagnosis and treatment were finally being made a priority, we’ve run out of medication."

"We must not allow this to continue," he added. "An urgent solution must be found for our patients.”

Various national Chagas programs in Latin America are already struggling to meet demand for new treatment and are expected to run out of stocks of benznidazole in the next few months. No information has been provided by the Brazilian Ministry of Health on the situation, and the World Health Organization (WHO) and Pan American Health Organization (PAHO) have not put a contingency plan in place to maintain stocks of the drug for acute cases of Chagas. Future availability of the drug is not known; according to various estimations it is unlikely to be before mid-2012.

In recent years, demand for treatment has increased significantly because adults are now being treated in addition to children. Additionaly, the WHO and PAHO have strongly endorsed diagnosis and treatment at the primary healthcare level. However, all progress made to date is now jeopardized by the shortage of benznidazole.

“Although we know that current treatment is more effective and more likely to prevent complications the sooner a patient is treated, we will be forced to delay it,” said Dr. Unni Karunakara, MSF international president.

MSF has called upon the Brazilian Ministry of Health to commit to speeding up the current benznidazole manufacturing process by streamlining its validation with the API produced by Nortec. Given that the production, distribution, and sales process will last for several months, Brazil must spearhead a regional contingency plan—with the support of PAHO—for the rational use of benznidazole stocks among the most vulnerable groups in endemic countries. MSF is also urging the Ministries of Health of endemic countries to demand this contingency plan be put in place as soon as possible, while finding a definitive solution for the long term.

“The Brazilian government has been pioneering in the production of generic drugs, showing its commitment to people who need access to treatment,” said Dr. Karunakara. “It must now act swiftly to keep its commitment to Chagas patients worldwide.”

___________________ About Chagas disease:

Chagas disease, also known as Human American Trypanosomiasis, is an infectious disease caused by the parasite Trypanosoma cruzi. Endemic in several Latin American countries, it causes 12,500 deaths per year and it is estimated that 8 to 10 million people have the disease. Case numbers are also rising in the US, Europe, Australia, and Japan as a result of greater international travel.

In most Latin American countries, the disease is primarily transmitted by the “assassin bug,” although it can also be transmitted from mother to child, through blood transfusions, organ transplants, contaminated food, and laboratory accidents. Because the infection is usually asymptomatic, most patients are unaware that they have it. However, as the disease progresses, roughly 30 percent of patients develop heart lesions and 10 percent suffer potentially fatal gastrointestinal damage.

Until recently, treatment was thought only to be effective in the acute stage of the disease (up to three months after being infected) and in its very early chronic stage. However, studies now show that treatment can also be effective in the chronic stage. In recent years, it was also found that the side effects of benznidazole, which are more common in adults, are manageable, and that treatment is feasible under supervision in primary healthcare settings.